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(Circulation. 2005;111:1337-1338.)
© 2005 American Heart Association, Inc.

Special Reports

Clinical Trial Registration

A Statement From the International Committee of Medical Journal Editors

Catherine De Angelis, MD, MPH, Editor-in-Chief, Journal of the American Medical Association; Jeffrey M. Drazen, MD, Editor-in-Chief, New England Journal of Medicine; Frank A. Frizelle, MB, ChB, MMedSc, FRACS, Editor, The New Zealand Medical Journal; Charlotte Haug, MD, PhD, MSc, Editor-in-Chief, Norwegian Medical Journal; John Hoey, MD, Editor, Canadian Medical Association Journal; Richard Horton, FRCP, Editor, The Lancet; Sheldon Kotzin, MLS, Executive Editor, MEDLINE, National Library of Medicine; Christine Laine, MD, MPH, Senior Deputy Editor, Annals of Internal Medicine; Ana Marusic, MD, PhD, Editor, Croatian Medical Journal; A. John P.M. Overbeke, MD, PhD, Executive Editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine); Torben V. Schroeder, MD, DMSc, Editor, Journal of the Danish Medical Association; Hal C. Sox, MD, Editor, Annals of Internal Medicine; Martin B. Van Der Weyden, MD, Editor, The Medical Journal of Australia

Donald Heistad MD Editor-in-Chief, Arteriosclerosis, Thrombosis, and Vascular Biology Joseph Loscalzo MD, PhD Editor-in-Chief, Circulation Eduardo Marbán MD, PhD Editor, Circulation Research John E. Hall PhD Editor-in-Chief, Hypertension Vladimir Hachinski MD Editor-in-Chief, Stroke Ivor J. Benjamin MD, FAHA Chair, American Heart Association Scientific Publishing Committee We, the Editors and the Scientific Publishing Committee of the American Heart Association journals, support the principles enunciated in the editorial "Clinical Trial Registration: A Statement From the International Committee of Medical Journal Editors." We look forward to working together in addressing the details of their implementation.

Key Words: trials, clinical • ethics, clinical • registries • research design

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Altruism and trust lie at the heart of research on human subjects. Altruistic individuals volunteer for research because they trust that their participation will contribute to improved health for others and that researchers will minimize risks to participants. In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly. Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product.

Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision-making. Researchers (and journal editors) are generally most enthusiastic about the publication of trials that show either a large effect of a new treatment (positive trials) or equivalence of two approaches to treatment (non-inferiority trials). Researchers (and journals) typically are less excited about trials that show that a new treatment is inferior to standard treatment (negative trials) and even less interested in trials that are neither clearly positive nor clearly negative, since inconclusive trials will not in themselves change practice. Irrespective of their scientific interest, trial results that place financial interests at risk are particularly likely to remain unpublished and hidden from public view. The interests of the sponsor or authors notwithstanding, anyone should be able to learn of any trial’s existence and its important characteristics.

The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice. Rather than . . . [Full Text of this Article]

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